TheraRadar
Data updated: May 26, 2026

MEGESTROL ACETATE

Infectious Disease Approved 1988-08-08

MEGESTROL ACETATE is indicated for the treatment of Anorexia; Cachexia; Weight Loss; Acquired Immunodeficiency Syndrome.

Source: FDA Label • NOVITIUM PHARMA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
12
Indications
--
Phase 3 Trials
37
Years on Market

Details

Status
Prescription
First Approved
1988-08-08
Routes
ORAL
Dosage Forms
SUSPENSION, TABLET

Companies

NOVITIUM PHARMA PHARMOBEDIENT USL PHARMA Teva CHARTWELL STRIDES PHARMA INTL Hikma TWI PHARMS
Active Ingredient: MEGESTROL ACETATE

MEGESTROL ACETATE Approval History

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Original
New Indication
New Form
Label Update
125 FDA actions from 1988 to 2020
May 2020 SUPPL
Label · Labeling
May 2020 SUPPL
Label · Labeling
Apr 2020 SUPPL
Label · Labeling

What MEGESTROL ACETATE Treats

4 indications

MEGESTROL ACETATE is approved for 4 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anorexia
  • Cachexia
  • Weight Loss
  • Acquired Immunodeficiency Syndrome
Source: FDA Label

MEGESTROL ACETATE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

6

Same indication, different mechanism — what else might this patient receive?

CIDOFOVIR
Viatris
2012 2 indic.
VALCYTE
CHEPLAPHARM
2001 3 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to MEGESTROL ACETATE

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

MARINOL
DRONABINOL
2 shared
ALKEM LABS LTD
Shared indications:
AnorexiaAcquired Immunodeficiency Syndrome
CIDOFOVIR
CIDOFOVIR
1 shared
Viatris
Shared indications:
Acquired Immunodeficiency Syndrome
FOSCAVIR
FOSCARNET SODIUM
1 shared
CLINIGEN HLTHCARE
Shared indications:
Acquired Immunodeficiency Syndrome
View all 6 similar drugs Pro
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Clinical Trial Registry

22 trials
Trial Sponsor ID Phase Status Title
NCT05538897 NCI-2022-07505 NCI-2022-07505, NRG-GY028 Ph 1, Ph 2 active not recruiting Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
NCT04939090 A222004 NCI-2021-03303, UG1CA189823 Ph 3 active not recruiting Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
NCT07436793 INST UNM 2502 PRO-WINDOW NCI-2025-06611, INST UNM 2502 PRO-WINDOW Ph 2 not yet recruiting Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
NCT04576104 NCI-2020-07529 NCI-2020-07529, NCI20-02-01 Ph 2 active not recruiting Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
NCT03671811 results posted 17327 NCI-2018-01555, 17327 Ph 2 active not recruiting Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
NCT06998758 MATRIX E2025078 Ph 3 recruiting Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
NCT07254416 AKZ-ADC-01 Ph 4 not yet recruiting A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
NCT03815019 iKanEat results posted STUDY00142352 Ph 4 completed iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children
NCT04491643 53211029-02 Ph 2 completed Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma
NCT05255653 RAINBO RAINBO ENGOT-en14-1,2,3,4, CCTG EN.10 TAPER arm A POLE Ph 2, Ph 3 recruiting Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
NCT03241888 2017-30-1 Ph 2, Ph 3 completed Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
NCT04607252 V01 2020-10 Ph 2, Ph 3 terminated Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
NCT04491682 53211029-01 Ph 2, Ph 3 completed Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
NCT05332483 MA-EEC 4858 Ph 1 terminated Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer
NCT04897217 IRB00074615 WFBCCC 99321, P30CA012197 Ph 3 withdrawn Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia
NCT02269670 results posted IRB00071229 NCI-2014-02092, WINSHIP2563-13 Ph 2 terminated Phase II Study of Everolimus Beyond Progression
NCT01968317 results posted 134119a4500 Ph 2 completed Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
NCT03241914 2017-30-2 Ph 2, Ph 3 completed Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
NCT00729586 results posted NCI-2009-01085 NCI-2009-01085, GOG-0248 Ph 2 completed Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer
NCT01200602 results posted MC0896 NCI-2010-01938, 09-007533 Ph 2 terminated Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
NCT01943058 5U-12-1 NCI-2013-01725, 5U-12-1 Ph 2 withdrawn Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer
NCT01501396 201202023 Ph 2 withdrawn Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MEGESTROL ACETATE FDA Label Details

Indications & Usage

MEGESTROL ACETATE is indicated for the treatment of Anorexia; Cachexia; Weight Loss; Acquired Immunodeficiency Syndrome.

Looking for the branded version?

MEGACE

Full clinical data, patents, trials, and competitive landscape for megestrol acetate.

See MEGACE

Data Sources

FDA Approval: ANDA077404 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.